The Promise
Theranos, a medical device company, was founded in 2003 by 19-year-old Elizabeth Holmes. It created a device called Edison, that Theranos claimed could perform hundreds of tests with a tiny amount of blood taken from a finger prick (Ledford, 2019). Theranos and Holmes promised to jumpstart a new era of preventative medicine by detecting health issues before it is too late. The process was simple, fast, and very affordable, with blood tests costing approximately 90% less than traditional blood testing methods (Weinstein et al., 2016).
The Downfall
Unfortunately for Theranos, the promise far outweighted the delivery. Theranos was only able to test for a small fraction of test advertised and was relying on devices made by other companies to test their blood samples (McCarthy, 2016). Theranos’ laboratory certificate was revoked for concerns of jeopardy of patient healthy and safety, and the owners and operators of the lab were suspended from running a lab for at least two years.
Elizabeth Holmes settled with the SEC in 2018 for a $500,000 fine, over 19 million shares of company stock, and agreed to not hold any type of leadership position for 10 years. Both Holmes and Ramesh “Sunny” Balwani, the president of Thanos, are chared with wire fraud based on their deceptive practices promoting their company and technology. That litigation is still ongoing.
How could Thanos have been saved?
Theranos hit a chord in the biotechnology market because there is a strong desire for preventative medicine, as well as medicines that are tailored to the patient. Unfortunately, Holmes resorted to deceptive practices to raise funds and relied on her charisma and refined public image to bolster the company in the absence of peer-reviewed published test data. Holmes had the charisma to make any company profitable, but she should have started with what she could deliver. She wanted too much too fast, and it caused the downfall of her reputation, career, and company.
The Sociotechnical Plan and Precision Medicine
Precision medicine is not ready for the market but gives the promise that medicine can eventually be tailored to a person based on their unique genomic makeup, increasing the odds that it will meet the expected outcomes, and minimize unnecessary side effects. This technology is becoming more possible because human genome sequencing is becoming more probable, and electronic copies of this information can be used with algorithms to identify patients with specific risk factors.
Precision medicine introduces privacy concerns. If a genome is sequenced for purposes of precision medicine, and it becomes used in healthcare data warehouses, what happens if a person wants to remove their information from those databases? How can a person know that their genomic data was completely anonymized before entry in a data warehouse? If a person is identified as having risk factors, could those genetic test results negatively affect employment or insurance coverage (Stiles & Appelbaum, 2019)?
Genomic data is not like personal credit information. Credit card and banking numbers can be changed, but our genomic data is the same over time. The potential mismanagement of this data can have serious effects for participants and needs to be a serious consideration as we move forward with precision medicine.
References
Ledford, H. (2019). Blood money: Theranos on screen. Nature, 568(7753), 455-456. https://doi.org/http://dx.doi.org/10.1038/d41586-019-01066-0
McCarthy, M. (2016). US officials ban Theranos CEO from running laboratories for two years. BMJ : British Medical Journal (Online), 354. https://doi.org/http://dx.doi.org/10.1136/bmj.i3824
Stiles, D., & Appelbaum, P. S. (2019). Cases in Precision Medicine: Concerns About Privacy and Discrimination After Genomic Sequencing. Annals of internal medicine, 170(10), 717-721. https://doi.org/10.7326/M18-2666
Weinstein, A., Sipala, A., Turkington, L., & Stromberg, M. (2016). Theranos - A Case Study on Customer Value and Technology. Journal of Marketing Perspectives, 1, 6-22.
No comments:
Post a Comment